April 03, 2014

The Food and Drug Administration (FDA) announced a new conflict of interest guidance entitled Public Availability of Advisory Committee Members' Financial Interest Information and Waivers. The guidance focuses on FDA's waiver policy regarding financial conflicts of Special Government Employees (SGEs), the technical name for advisory committee (AC) members who are not members of FDA or other agencies of the government. Because of the complexity inherent in medical innovation, SGEs often include scientists and doctors with highly specialized skills and experience. These well-qualified experts often also have financial ties to industry.

The same day the FDA announced its guidance, March 31st, we covered the 63rd annual meeting of the American College of Cardiology in Washington, DC. The meeting included a conflicts of interest session in which Jill Hartzler Warner, the Associate Commissioner for Special Medical Programs with FDA, spoke to FDA's conflict of interest procedures regarding advisory committees. Hartzler oversees FDA's Advisory Committee Oversight and Management staff, which develops the policies on conflicts of interests for advisory committee members who are external to the agency and thus may have other interests. Interestingly, Hartzler didn't specifically mention the new guidance, but described concepts that appear in it.

According to Hartzler, FDA's challenge and goal is to maintain public confidence in the advisory committee process and to obtain the best expert advice. These goals have resulted in an expansive conflicts of interest policy and an enhanced effort to identify non-conflicted experts. FDA conflict of interests procedures also focus on nonfinancial bias and removing even the "perception" of conflicts of interest.

"FDA implements a rigorous process for soliciting and vetting candidates for advisory committee meetings to minimize any potential for financial conflicts of interest," FDA explains in the guidance. "In preparation for advisory committee meetings involving particular matters, SGEs invited to participate in the meetings are required to report to FDA any financial interests related to the subject matter of the advisory committee meeting."

Unfortunately, rigorous conflict-of-interest rules may keep many of the most knowledgeable academic and industry scientists off advisory committees out of fear that industry ties might bias their judgment.

FDA understands that given advisory positions are temporary, many specialists will have outside jobs which include industry ties. Thus, FDA focuses on managing potential conflicts of interests. "Typically, because the advisory position at FDA is a part time job, they don't want to divest their interests. It comes down to should they be recused from participation or should a waiver be granted," Hartzler stated.

Hartzler notes that FDA advisors are Special Government Employees, and that is the basis of the Federal requirements that pertain to financial conflicts of interests. Federal standards of conduct for government employees apply, with a few regulatory exemptions.

In identifying potential conflicts of interests, SGEs submit a confidential financial disclosure statement to the FDA that identifies potential conflicting financial interests. SGEs submit FDA Form 3410 that identifies current assets, income, outside positions, consulting, grants, contracts, patents, and speaking or writing arrangements that may have an association with the sponsor or topic coming before the committee.

The law prohibits all employees (including SGEs) from participating in any particular government matter that will have a "direct and predictable effect on their financial interests." It also prohibits employees from acting in government matters that will affect the financial interests of others with whom they have certain relationships. These are known as imputed interests.

Whose Interests

Which Interests

Exceptions

Exemptions

SGE

Spouse

Minor child

General partner

Organization in which SGE serves as officer, director, trustee, or employee- this is very broad in scope.

Prospective employer in a case where there is negotiation for employment.

Stocks and investments

Primary employment

Consulting or advising

Grants, contracts to study a particular product

Patents/Royalties/ trademarks

Serving as expert witness

Speaking/writing arrangements

SGEs can participate in matters of general applicability where the interest that creates the conflict arises from the SGE's non-federal employment. As long as the matter does not impact the employer or employee other than as a part of a class.

Diversified mutual funds

Publicly traded securities – matter involving specific parties

<$15k sponsor, <$25k competitors of sponsor

Publicly traded securities – matter of general applicability

<$25k one company;

<$50k aggregate

If a conflict is identified, FDA has three decisions regarding its SGE:

SGE could sell or divest his or her interest. As we stated above, this would be unlikely given the part-term work

Recusal/disqualification

Waiver may be granted if the need for their service outweighs the potential for a conflict of interest. FDA publicly discloses all waivers to their website

The guidance document states: "FDA is directed to disclose on its website the type, nature, and magnitude of the financial interests of each advisory committee member who has received a waiver under 18 U.S.C. § 208 and the reasons for granting each waiver prior to the advisory committee meeting, including, as appropriate, the public health interest in having the expertise of the member with respect to the particular matter" (emphasis added).

FDA also said it intends to make advisory committee meeting participation contingent upon a SGE's "acknowledgement of FDA's intention to publicly disclose" information about the type, nature, and magnitude of any waived financial interests. This information will be published using a template provided by the guidance (page 10).

Additionally, FDA plans to post a roster of all advisory committee members expected to attend a specific meeting at the same time briefing materials for that meeting are posted.